MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS

Model Number 1104

Device Problem Increase in Suction (1604)

Patient Problem Dehydration (1807)

Event Date 09/13/2020

Event Type  Injury  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation per d00595825 due to an fda audit observation.Product event summary: (b)(4) was not returned for evaluation.The reported suction alarm was confirmed via log file analysis which revealed nineteen (19) suction alarms between (b)(6) 2020 and (b)(6) 2020.Information provided by the site indicated that the patient had no subjective symptoms.The patient was instructed to drink plenty of water.However, the instruction was not being followed well.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported suction event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or poor vad filling, and/or patient related factors.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.

Event Description

It was reported that review of logfiles showed multiple ventricular assist device (vad) suction alarms.It was noted that the patient had no subjective symptoms.The patient was instructed to drink plenty of water because they become dehydrated early in the morning.However, the instruction was not being followed well.The vad remains in use.No further patient complications have been reported as a result of this event.

Event Description

It was reported that review of logfiles showed multiple ventricular assist device (vad) suction alarms.It was noted that the patient had no subjective symptoms.The patient was instructed to drink plenty of water because they become dehydrated early in the morning.However, the instruction was not being followed well.The vad remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.Product event summary: (b)(4) was not returned for evaluation.The reported suction alarm was confirmed via log file analysis which revealed nineteen (19) suction alarms between 09/sep/2020 and 04/oct/2020.Information provided by the site indicated that the patient had no subjective symptoms.The patient was instructed to drink plenty of water.However, the instruction was not being followed well.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported suction event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or poor vad filling, and/or patient related factors.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13500016
• MDR Text Key: 285713092
• Report Number: 3007042319-2022-02440
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female